Marketing authorisation application checklist for Global Regulatory Affairs Directors
Effective labelling is not just a regulatory necessity, it’s essential for patient trust and product success. In this article, we aim to share valuable insights on vital labelling considerations, common pitfalls, and best practices to help guide you toward a seamless MAA/NDA/BLA experience.
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Agree on the regulatory strategy
Prior to submission of a MAA, the labelling is developed based on cross-functional expertise and applicable regulations. The importance of a clear and communicated regulatory strategy can not be emphasized enough. Important questions to answer are:
- What are our aims for the product? What is the intended indication(s)?
- Which fallback positions do we have if the Health Authorities will not accept our claims?
To avoid confusion and delays, the cross-functional team of experts should agree on the overall strategy before study data is received.
Availability for expert input to the label must also be ensured. This input will be crucial as the submission date of the MAA/NDA/BLA is approaching.
Understanding regional labelling requirements
Regions have their own set of labelling regulations that can impact your marketing strategy. It’s crucial to understand and stay attuned to these nuances. Defining the most favourable game plan for your specific case might require support from experienced specialists.
European Union (EU)
The Summary of Product Characteristics (SmPC) guideline is essential for EU labelling. Even though the guideline is detailed, there is still room for interpretation. Making the right decisions about how to present your data and choices of wording is critical.
Find the SmPC guideline here
The most important consideration is if the Health Authority will accept the data that supports the new MAA/NDA/BLA and the internally agreed indication wording.
United States
With the FDA setting rigorous standards under 21 CFR Part 201, it’s important to ensure your labels are clear and comprehensive, covering everything from ingredient listings to risk statements.
Find the FDA guideline here
To avoid delays, or even refusal, we recommend a proactive approach. A detailed internal review process can serve as your safety net and prevent risk of failure in meeting the FDA’s criteria. Keeping your labelling strategy expert involved along the journey is valuable, as it helps you create a compliant high-quality label before submission.
Labelling across markets
Labelling guidelines in one region can often set the stage for acceptance in others; for example, EU approval can facilitate a smoother approval process elsewhere. Striving for uniformity in labelling is ideal. However, it’s important to appreciate the implications of diverse regulations.
Inconsistencies between regions may inadvertently lead to regulatory challenges. Implementing a centralised system to monitor and harmonise labelling updates can be a game-changer. Such a system will help you create consistency and clarity across your global portfolio.
Safety information
Your labels must include clear and updated sections on adverse drug reactions. The requirements to articulate post-market surveillance responsibilities differ between regions. There are cases where no post-marketing data is required, even for products that have been on the market for some time. This information is included in the Adverse Drug Reaction (ADR) table.
If the adverse drug reaction/adverse event section is not up to date or incorrect, it could lead to painful regulatory repercussions, including fines or recalls. Regular consultations with WHO and HA guidelines is recommended to stay ahead of potential issues.
Changes in the regulatory environment
The regulatory landscape is perpetually evolving, and staying ahead of these changes is a must for market readiness. A new guideline in one market can ripple across others, prompting preemptive labelling adjustments worldwide. Such a development might impact the global regulatory strategy.
Ignoring updates can lead to non-compliance and refusal of the MAA/NDA/BLA at worst and missed opportunities at best. It’s wise to establish a dedicated Regulatory Intelligence team/function to monitor regulatory changes. This will help you ensure timely updates to your labelling and safeguard your market position.
Conclusion
Close attention to labelling requirements across regions is an indisputable key to MAA/NDA/BLA success. Informed decisions make all the difference.
Collaborating with global labelling specialists can offer you a rock to lean on when navigating the maze of requirements. A solid strategy and plan go a long way. Having the right expertise on your team offers you support and confidence through tight timelines and complex regulations
The Arex Regulatory Affairs team has the skills and experience to complete your team in global MAA projects.
Read more about our services here:
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